💬In plain words
What the trial is, and whether it could suit you
This randomized trial will compare daily tadalafil 5 mg as adjunct therapy versus monotherapy in men with on-demand PDE5 inhibitor-resistant erectile dysfunction. The study will evaluate changes in erectile function, treatment satisfaction, partner satisfaction, and safety over 12 weeks.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria
* Age: 18 to 70 years.
* Diagnosis: Erectile dysfunction for at least 6 months.
* PDE5 inhibitor resistance: History of on-demand PDE5 inhibitor use for at least 3 months with inadequate response, defined as:
* International Index of Erectile Function-Erectile Function score less than 26 despite optimal dosing.
* Self-reported inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse in at least 50% of attempts.
* Confirmed proper medication use with at least 4 to 8 attempts with adequate sexual stimulation.
* Stable relationship: Sexually active with a female partner for at least 6 months.
* Informed consent: Willing and able to provide written informed consent.
Exclusion Criteria
* Current use of nitrates.
* Unstable cardiovascular disease, including recent myocardial infarction within 6 months, unstable angina, or severe heart failure.
* Uncontrolled hypertension greater than 180 over 110 mmHg or severe hypotension less than 90 over 50 mmHg.
* Severe hepatic impairment, Child-Pugh class C, or renal impairment with estimated glomerular filtration rate less than 30 mL per minute per 1.73 m².
* Untreated hypogonadism, total testosterone less than 250 ng/dL.
* Severe penile anatomic deformity or prior penile prosthesis.
* History of priapism.
* Severe untreated depression.
* Pelvic surgery or radiation within 6 months.
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